Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers

A Phase 1 Randomized, Double Blinded, Placebo-Controlled Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of 611 in Adult Healthy Male and Female Volunteers

This is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation study to evaluate the safety, tolerability, and PK of 611 in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: 611

Detailed Description

Total duration of the study period per subject is about 4 months broken down as follows:

The screening period is up to 28 days, one dose treatment, and follow- up period is up to 71±7 days (90±9 days for Cohorts 1 and 2).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Covance Dallas Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Able to understand and willing to sign the ICF
2. Healthy male and female subjects, non-smokers, 18-55 years of age
3. In the opinion of the investigator, with no significant medical history, and in good health.
4. Body mass index 19.0-32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
5. Subjects are able to follow the study protocol and complete the trial.

Exclusion Criteria:

1. History of hypersensitivity to similar drugs to 611 or their excipients.
2. Pregnant, or nursing females.
3. HepBsAg or HepCAb positive.
4. Human immunodeficiency virus (HIV) positive.
5. Positive urine drug screen, or cotinine test.
6. Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; 611 dose 1 (45mg) plus placebo	Drug: Placebo; placebo as a single SC injection on Day 1; Drug: 611; 611 as a single SC injection on Day 1;
Experimental: Cohort 2; 611 dose 2 (150mg) plus placebo	Drug: Placebo; placebo as a single SC injection on Day 1; Drug: 611; 611 as a single SC injection on Day 1;
Experimental: Cohort 3; 611 dose 3 (300mg) plus placebo	Drug: Placebo; placebo as a single SC injection on Day 1; Drug: 611; 611 as a single SC injection on Day 1;
Experimental: Cohort 4; 611 dose 4 (450mg) plus placebo	Drug: Placebo; placebo as a single SC injection on Day 1; Drug: 611; 611 as a single SC injection on Day 1;
Experimental: Cohort 5; 611 dose 5 (600mg) plus placebo	Drug: Placebo; placebo as a single SC injection on Day 1; Drug: 611; 611 as a single SC injection on Day 1;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With TEAEs	Incidence of treatment-emergent adverse events (TEAEs) will be summarized by SOC and PT for each treatment group, and also be summarized by severity and association with the study treatments.	up to 71days (90 days for Cohorts 1 and 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK	PK parameters not limit to Cmax	up to 71days (90 days for Cohorts 1 and 2)
Incidence of immunogenicity	ADA, and NAbs if ADA is positive	up to 71days (90 days for Cohorts 1 and 2)

Collaborators and Investigators

• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2020
• Primary Completion (Actual): August 13, 2021
• Study Completion (Actual): August 13, 2021

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: SSGJ-611-HV-I-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No